Job Title: Associate Engineer, Biotech (JP10225) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: DP Process and Equipment Capabilities Duration: 3 years with likely conversion to permanent. Posting Date: 5/10/2022
3 Key Consulting is hiring an Associate Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: As a member of the process development team, this role will be focused on characterizing new fill finish technologies and advancing the state of the drug product manufacturing process. The candidate will be primarily responsible for executing filler characterizations studies using complex fillers organizing data and analyzing results with minimal supervision.
The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. Engineer responsibilities include, but are not limited to, the following:
Independently design and execute experiments in order to characterize and enable implementation of new capabilities such as filling, lyophilization and analytical technologies
Serve as single point of contact and subject matter expert (SME) on complex capabilities.
Own business process and responsible for maintaining line time request forms and metrics
Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results
Troubleshoot malfunctioning equipment, work with system owners, Asset Management, Facilities and vendors to repair
Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
Perform tasks related to safety and compliance initiatives in the lab.
Manage procurement and inventory levels of commonly used lab supplies and chemicals
Manage dynamic project schedules and timelines
B.S. with 2‒3 years of industry experience, M.S. with 1‒2 years’ experience, with degree in Engineering
Previous experience in drug product/ drug substance manufacturing or process development labs
Knowledge of and hands-on experience with various drug product technologies, particularly filling technology
Displayed critical thinking, problem solving and independent research skills
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Good computer and organizational skills with strong attention to detail Excellent communication (oral and written)
Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management
Self-motivation, adaptability and a positive attitude
Ability to work independently and as part of a team with internal and external partners
Experience working in GMP environments or process development
Light to moderate lifting and carrying of 15-44lbs, reach above and below shoulder height. Need color perception/discrimination, far vision correctable with eye glasses
Why is the Position Open? Staff Augmentation
Top Must Have Skills:
Experience with authoring and reviewing SOPs
Experience with large molecule proteins
Prior experience with filling equipment preferred but not required.
Day to Day Responsibilities: Support of B6 Pilot plant to operate commercial filling equipment for tech transfers to clinical and commercial sites.
Employee Value Proposition: The person in this role will work with large molecule proteins and learn how to perform technology transfers. This team works with clinical sites and does clinical fill transfers. You will learn cross functional collaboration through working with many teams.
Red Flags: Candidates who intend to apply for graduate school in the short future Many jobs within a short period of time
Interview process: 1) Phone (30 mins)
2) Virtual with team (1-2 hrs)
3) Possible on-site with team (2-3 hrs)